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A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Compare the Efficacy and Safety of Bexagliflozin to Placebo in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM).
Details
| Lead sponsor | Theracos |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 210 |
| Start date | 2016-03 |
| Completion | 2017-04 |
Conditions
- Type 2 Diabetes Mellitus
Interventions
- Bexagliflozin
- Placebo
Primary outcomes
- Change in HbA1c From Baseline at Week 24 — 24 weeks
Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method.
Countries
United States, Canada